Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners

Pain Clinical Trial

Official title:

Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01762735
• Other study ID #: WIC-002
• Status: Recruiting
• Phase: N/A
• First received: January 3, 2013
• Last updated: February 10, 2013
• Start date: February 2013
• Est. completion date: March 2013

Study information

• Verified date: February 2013
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Youlin Yang, M.D.
• Phone: 8613604809322
• Email: dr.yangylin[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Water injection colonoscopy has been a generally accepted method in training the beginners of colonoscopy for its low pain and less cecal intubation time, we would conduct this study to investigate more advantages of this method and make most use of it for beginners' training.

Description:

Colonoscopy is the gold standard for diagnosing the large bowel diseases, caecum intubation is the success of the colonoscopy, although with the progress of the function and the technique, for most patients, when facing with inexperienced examiners, conventional air insufflation colonoscopy is still a painful experience. Despite of the application of the technique of abdomen compression, position change of the patients and the sedatives or analgesics, to master well of the colonoscopy for the first-learners still needs much practice.

Up to now, many studies has showed that compared with air insufflation colonoscopy, water-related colonoscopy could shorten the cecal intubation time and relieve the pain of the patients,especially for training the beginners，the effect was notable, but the present researches on water assisted technique has still been confined to following aspects:1.Water infusing was based on air insufflation; predetermined amount of water was infused ,and water was infused while passing through certain segment of the bowel(such as the left half of colon) ; 2.When training the first-learners, certain dose of sedatives or analgesics was injected; 3.The patients recruited were less. Colonoscopies in this study would be performed by in-training examiners, water would be injected completely instead of air insufflation while advancing the colonoscope, the amount of the water infused would not be predetermined but vary from individuals, and all the patients would be examined without any sedatives or analgesics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients diagnostic colonoscopy;

• Subjets able to provide informed consent

Exclusion Criteria:

• Prior partial or complete colectomy;

• Patients who decline to participate;

• Patients with poor bowel preparation;

• Contraindications of the colonoscopy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colon Disease
• Colonic Diseases
• Pain
• Rectal Disease
• Rectal Diseases

Intervention

Other:
• Air insufflation
Air is inflated into the bowel to help searching the cavity while advancing the colonoscope until reaching the cecum.
• Water injection
Water was injected through the working channel instead of air to follow the intestinal cavity until reaching the caecum.

Locations

Country	Name	City	State
China	The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Youlin Yang ,MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of the cecal intubation within 15 min(%)		This will be calculated after the completion of the whole trial,which is about 2 months	No
Secondary	The cecal intubation time(min);		This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length	No
Secondary	The time to reach the splenic flexure(min)		This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length	No
Secondary	VAS abdominal pain score		Data collected usually within 10minutes post procedure	No
Secondary	The frequency of the colonoscope shortening maneuver while advancing the colonoscope		This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.	No
Secondary	Length of colonoscope at time of cecal intubation(cm)		This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.	No
Secondary	Volume of water used during water colonoscopy(ml)		This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.	No
Secondary	General data of the patients recruited-age		Data collected usually within 10minutes post procedure .	No
Secondary	General data of the patients recruited-gender		Data collected usually within 10minutes post procedure .	No
Secondary	General data of the patients recruited-BMI		Data collected usually within 10minutes post procedure .	No
Secondary	General data of the patients recruited-abdominal or pelvic surgery history		Data collected usually within 10minutes post procedure .	No
Secondary	General data of the patients recruited-bowel preparation		Data collected usually within 10minutes post procedure .	No